Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

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What are outsourcing facilities subject to?

  1. Only NDA requirements

  2. Only state pharmacy board regulations

  3. FDA inspection

  4. Exemption from FDA oversight

The correct answer is: FDA inspection

Outsourcing facilities are subject to FDA inspection because they are regulated under the Drug Quality and Security Act (DQSA) by the FDA. This means that they must comply with federal regulations, including those related to safety and quality of drugs being produced and distributed by the facility. Options A and D are incorrect because NDA requirements and exemption from FDA oversight are not the only regulations that outsourcing facilities must comply with. Option B is also incorrect because although state pharmacy board regulations may apply in some cases, they do not supersede federal regulations and oversight by the FDA.

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